FDA.reportPublic FDA data

EZ Drape

Primary DI
10814639022046
Brand
EZ Drape
Company
APPLIED DENTAL, INC.
Model
A400-1000
Catalog number
A400-1000
Device description
Dental Disposable hose covers
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814639022046PackageGS124In Commercial Distribution
20814639022043PackageGS124In Commercial Distribution
00814639022049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081463902204610814639022046
2081463902204320814639022043
00814639022049008146390220498146390220490814639022049

GMDN Terms#

Term, Definition table
TermDefinition
Surgical dressing/drape kit, single-useA collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-841-8481info.usa@AD-Surgical.com

Regulatory Flags#

DUNS number
017524666
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814639026747Premium UNIFY Silk SuturesPMS-318R192025-06-20
10814639026754Premium UNIFY Silk SuturesPMS-418R192025-06-20
10814639026761Premium UNIFY Silk SuturesPMS-518R192025-06-20
10814639026778Premium UNIFY Silk SuturesPSS-418R132025-06-20
10814639026785Premium UNIFY Silk SuturesPSS-518R132025-06-20
10814639026792Premium UNIFY Silk SuturesPSS-618R132025-06-20
10814639026563UNIFY Chromic Gut Surgical SuturesM-C318R192025-06-19
10814639026587UNIFY Chromic Gut Surgical SuturesM-C418R162025-06-19
10814639026594UNIFY Chromic Gut Surgical SuturesM-C518R162025-06-19
10814639026600UNIFY Chromic Gut Surgical SuturesS-C618R132025-06-19
10814639026617UNIFY Plain Gut SuturesS-J618R132025-06-19
10814639026624UNIFY Plain Gut Surgical SuturesL-J230R24L-J230R242025-06-19
10814639026648UNIFY Plain Gut SuturesM-J318R192025-06-19
10814639026655UNIFY Plain Gut SuturesM-J418R162025-06-19
10814639026662UNIFY Plain Gut SuturesM-J430R19M-J430R192025-06-19
10814639026679UNIFY Plain Gut SuturesM-J518R162025-06-19
10814639026686UNIFY Chromic Surgical Sutures M-C518R19 2025-06-19
10814639026693UNIFY Plain Gut SuturesM-J518R192025-06-19
10814639026730UNIFY Polyester Surgical SuturesL-E230R262025-06-19
10814639026808UNIFY Polyester Surgical SuturesS-E418R132025-06-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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